A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA)

Abstract

Background We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA). Methods A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman’s history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as “not important”. In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as “not important” or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study. Results Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women. Conclusion We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery. Trial registration The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 (NCT04446780).

French guidelines for restrictive episiotomy during instrumental delivery were not followed by an increase in obstetric anal sphincter injury

“…Therefore, a large prospective national observational study appears to be the best approach to study this question. This study is currently ongoing in France in 120 maternity with 15,000 women planned to include (INSTRUMODA; NCT:04446780; https://clinicaltrials.gov ) 29 .…”

Prospective observational study investigating the effectiveness, safety, women’s experiences and quality of life at 3 months regarding cervical ripening methods for induction of labor at term—The MATUCOL study protocol

“….) are guided by a pragmatic view about cervical ripening, such as all large prospective observational studies in obstetrics [30][31][32][33]. These studies allow multiple analyses of data and conclusions about pragmatic management and consequences of some current obstetric conditions that were not adapted to randomized controlled trials (i.e., twins with The JUmeaux MODe d'Accouchement (JUMODA) study) [30,[34][35][36][37][38][39].…”

Is Cesarean Section Protective against Anal Incontinence in Women after Obstetric Anal Sphincter Injury (OASI)? A Systematic Review and Meta-Analysis

“…Authors were contacted to provide data in a suitable format for meta-analysis if not supplied. Core outcome sets for OASI have not been published, but there are published protocols in development seeking to establish this for OASI (21), perineal trauma (22) and the effects of episiotomy and OASI (23). Patients and the public were not directly involved in conducting this review.…”